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Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence. HNC-TACTIC.

Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05117775
Acronym
HNC-TACTIC
Enrollment
10000
Registered
2021-11-11
Start date
2021-12-06
Completion date
2024-12-31
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

HNSCC, Predictive factors, Overall survival, Immunotherapy, Electronic health records, Natural language processing, Artificial intelligence

Brief summary

This will be an international, multicenter, retrospective, observational, and data-driven study using secondary data captured in EHRs. The extraction of the data captured in the EHRs will be performed with SAVANA's EHRead®, an innovative data-driven system based on Natural Language Processing (NLP) and machine learning. For all patients, the Index Date is defined as the timepoint within the study period when they fulfill ALL inclusion criteria and no exclusion criteria. Follow-up comprises the period between Index Date and the last EHR available within the study period. Additional variable-specific time windows may be considered to optimize data collection.

Detailed description

The present study aims to describe the clinical characteristics of patients with HNSCC in a real-world setting by analyzing readily available information in the Electronic Health Records (EHRs). This study will gain a deep insight of the clinical characteristics and real-world outcomes of patients with all stages (early, locally advanced, and metastatic) of HNSCC. It will focus on developing two predictive models to apply in the clinical setting, one for electing patients with high-risk of recurrence after radical treatment, and the second one for selecting recurrent or metastatic patients who could benefit from immunotherapy. To achieve the proposed study objectives we will use SAVANA´s EHRead® (11-15), a technology that applies Natural Language Processing (NLP) (16) and machine learning to extract, organize, and analyze the unstructured clinical information jotted down by health professionals in patients' EHRs. Primary objectives * To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease. * To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients. Secondary objectives * To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment. * To describe the demographics, clinical characteristics, and treatment of patients with HNSCC in early and locally advanced stages of the disease. * To describe the patterns of follow-up in patients with HNSCC in early and locally advanced stages of the disease. * Departments in charge * Number of visits * Imaging and anatomopathological tests * Recurrence detected by physical examination. * To evaluate the impact of treatments on patients with locally advanced stages of the disease. * Patients' early and late toxicity to the treatment, comparing between radiotherapy (+/-cisplatin or cetuximab) vs surgery and post-operative r\< radiotherapy (+/- cisplatin). * Healthcare resource utilization (HCRU), including medical visits, diagnostics, and hospitalizations. * To compare OS in locally advanced HNSCC patients (including both HPV+ and HPV- oropharyngeal patients) treated with cisplatin-radiotherapy vs cetuximab-radiotherapy and treated with surgery vs. conservative treatment. * To compare the demographic and clinical characteristics of exceptional responders and poor responders (based on recurrence and long-term survival). This analysis will be performed independently for HPV+ and HPV- oropharyngeal patients.

Interventions

OTHERNo intervention - Just description and predictive models

All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).

Sponsors

Savana Research
Lead SponsorNETWORK
Head and Neck Cancer International Group (HNCIG)
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ≥18 years old. * Patients diagnosed with HNSCC * For selected exploratory analyses, patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.

Exclusion criteria

* Patients with follow-up of less than 6 months, except if deceased (any cause) in the 6 months after HNSCC diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progressionFrom 1st Jan 2021To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease.
Predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' featuresFrom 1st Jan 2021To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients

Secondary

MeasureTime frameDescription
In all patients with all stages of HNSCC (full analysis set, FAS):From 1st Jan 2021To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment.
In patients with early and locally advanced stages of the disease (including all patients treated with curative intent):From 1st Jan 2021* To describe the demographics, clinical characteristics, and treatments * To describe the patterns of follow-up * Departments in charge * Number of visits * Imaging and anatomopathological tests * Recurrence detected by physical examination * To evaluate the impact of treatments on patients with locally advanced stages of the disease. * Patients' early and late toxicity to the treatment, comparing between radiotherapy (cisplatin or cetuximab) vs surgery and post-operative radiotherapy (cisplatin) * Healthcare resource utilization (HCRU), including medical visits, diagnostics, and hospitalizations. * To compare OS in locally advanced HNSCC patients (including both HPV+ and HPV- oropharyngeal patients) treated with cisplati
In patients with recurrent or metastatic disease:From 1st Jan 2021* To describe the epidemiologic and clinical characteristics, and treatments * To describe epidemiologic, clinical, and tumor characteristics of long-term survivors treated with immunotherapy and non-immunotherapy approaches. * To describe the impact of introducing immunotherapy in recurrent or metastatic HNSCC: * Treatment outcome: OS * HCRU, including medical visits, diagnostics, and hospitalizations.

Countries

Spain

Contacts

STUDY_CHAIRJohn Almeida

University Health Network and Mount Sinai Hospital

STUDY_CHAIRSujith Baliaga

Ohio State University

STUDY_CHAIRDavid Casadevall

Medsavana S.L

STUDY_CHAIRMelvin Chua

National Cancer Centre, Singapore

STUDY_CHAIRAndreas Dietz

University Hospital of Leipzig

STUDY_CHAIRRobert Ferris

UPMC Hillman Cancer Center

STUDY_CHAIRRaul Giglio

Hopital Ángel H. Roffo de Buenos Aires

STUDY_CHAIRChris Holsinger

Stanford University

STUDY_CHAIRKate Hutcheson

M.D. Anderson Cancer Center

STUDY_CHAIRHusham Menhanna

Institute of Head and Neck Studies and Education (InHANSE)

STUDY_CHAIRPablo Parente

Hospital HM Rosaleda

STUDY_CHAIRSandro Porceddu

Queensland Institute of Medical Research (QIMR)

PRINCIPAL_INVESTIGATORMiren Taberna

Medsavana S.L

STUDY_CHAIRChristian Simon

CHUV Lausanne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026